GLYBURIDE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

glyburide (UNII: SX6K58TVWC) (glyburide - UNII:SX6K58TVWC)

Dostupné s:

Aphena Pharma Solutions - Tennessee, LLC

INN (Mezinárodní Name):

glyburide

Složení:

glyburide 1.25 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Glyburide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide is contraindicated in patients: - With known hypersensitivity to the drug or any of its excipients. - With type 1 diabetes mellitus or diabetic ketoacidosis, with or without coma. These conditions should be treated with insulin. - Treated with bosentan.

Přehled produktů:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Glyburide tablets USP are available in the following strengths and package sizes: 1.25 mg (white to off-white, capsule-shaped, flat faced, beveled edge tablet debossed "GLYBUR" on one side and a score line on the other side). Bottles of 50         (NDC 0093-9477-53) 2.5 mg (pink, capsule-shaped, flat faced, beveled edge tablet debossed "GLYBUR" on one side and a score line on the other side). Bottles of 100       (NDC 0093-9433-01) Bottles of 500       (NDC 0093-9433-05) 5 mg (blue, capsule-shaped, flat faced, beveled edge tablet debossed "GLYBUR" on one side and a score line on the other side). Bottles of 100       (NDC 0093-9364-01) Bottles of 500       (NDC 0093-9364-05) Bottles of 1000     (NDC 0093-9364-10) Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature]. Dispense in well-closed containers with safety closures.

Stav Autorizace:

New Drug Application Authorized Generic

Charakteristika produktu

GLYBURIDE- GLYBURIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
GLYBURIDE TABLETS USP
1.25, 2.5 AND 5 MG
DESCRIPTION
Glyburide is an oral blood-glucose-lowering drug of the sulfonylurea
class. It is a white, crystalline
compound, formulated as tablets of 1.25 mg, 2.5 mg, and 5 mg strengths
for oral administration.
Glyburide tablets USP contain the active ingredient glyburide and the
following inactive ingredients:
dibasic calcium phosphate USP, magnesium stearate NF, microcrystalline
cellulose NF, sodium alginate
NF, talc USP. Glyburide 2.5 mg tablets USP also contain FD&C Red #40
Aluminum Lake. Glyburide 5
mg tablets USP also contain FD&C Blue #1 Aluminum Lake. Chemically,
Glyburide is identified as 1-
[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea.
The CAS Registry Number is 10238-21-8.
The structural formula is:
The molecular weight is 493.99. The aqueous solubility of Glyburide
increases with pH as a result of
salt formation.
CLINICAL PHARMACOLOGY
Glyburide appears to lower the blood glucose acutely by stimulating
the release of insulin from the
pancreas, an effect dependent upon functioning beta cells in the
pancreatic islets. The mechanism by
which Glyburide lowers blood glucose during long-term administration
has not been clearly
established.
With chronic administration in Type II diabetic patients, the blood
glucose lowering effect persists
despite a gradual decline in the insulin secretory response to the
drug. Extrapancreatic effects may play
a part in the mechanism of action of oral sulfonylurea hypoglycemic
drugs.
In addition to its blood glucose lowering actions, Glyburide produces
a mild diuresis by enhancement
of renal free water clearance. Clinical experience to date indicates
an extremely low incidence of
disulfiram-like reactions in patients while taking Glyburide.
PHARMACOKINETICS
Single-dose studies with Glyburide in normal subjects demonstrate
significant absorption within 1 hour,
peak drug levels at about 4 hours, and low but detectable levels at 24
hour